Stool specimen collector

ABSTRACT

The invention provides an apparatus for obtaining a stool specimen. The apparatus comprises a housing, a collection bag, a slider to close the collection bag and a draw string to move the slider. A user places the apparatus on a toilet, deposits a first stool into the collection bag, then pulls the draw string to move the slider to close the collection bag thereby allowing the user to urinate or further defecate.

RELATED APPLICATIONS

[0001] This application is a continuation in part of U.S. Ser. No.09/303,988 filed on May 3, 1999.

TECHNICAL FIELD

[0002] This invention relates generally to an apparatus for collectingbiological specimens. More particularly, the invention relates to anapparatus for the collection and transportation of stool specimens.

BACKGROUND OF THE INVENTION

[0003] Stool specimens are used with increasing frequency for thescreening and diagnosis of disease. Evidence of parasitic, infectious,or inherited disease may be found in stool. For example, the presence ofcarcinoembryonic antigen or blood in stool is indicative of colorectalcancer. Stool-based assays for parasitic organisms are also widelyavailable.

[0004] A significant problem with using stool specimens in screening ordiagnosis arises in the collection of the specimen. Depending on itsphysical state, the specimen may be difficult to collect into acontainer. Moreover, the handling of a specimen raises sanitaryconcerns. Merely obtaining a specimen may increase the risk of diseasetransmission, especially if sanitary procedures are not followed. Thisis especially true if the patient is responsible for obtaining thespecimen. The odor often associated with a stool specimen, and thefrequent need to transport the specimen also contribute to the problemsassociated with sample collection.

[0005] Attempts have been made to solve these problems. For example,Aslam, U.S. Pat. No. 4,101,279, reports a disposable bowl adapted to fitonto a toilet for collection of stool. Such a device eliminates the needfor the patient to handle the specimen directly. However, the patient(or technician) is still exposed to the sample, resulting in possiblecontamination and the presence of odor. Moreover, the Aslam devicecontains blades for homogenization that may present a danger to thepatient.

[0006] Paulin, U.S. Pat. No. 4,309,782, also reports a bag adapted tofit onto a toilet for collection of stool. The device reported by Paulinalso provides for scraping excess stool out of the bag after use.

[0007] While these and other devices of the art have attempted to solvethe problems associated with collection of stool, none have provided asolution that minimizes handling of the specimen, minimizes odor andcontamination, and provides for easy transport of the specimen.Accordingly, there remains a need in the art for a device for safe andsecure collection of stool.

SUMMARY OF THE INVENTION

[0008] The present invention provides an apparatus for a collecting,storing, and/or shipping a stool specimen. Generally, the inventionprovides a housing having attached thereto a retractable bag forcollecting the specimen. The bag is retracted by a draw string or cord(e.g., a lanyard) attached thereto, or preferably by a slider attachedto the housing and to which the draw string is attached for moving theslider. In use, the patient places a device of the invention on atoilet, deposits stool into the bag, and pulls the draw string therebyto engage the slider to retract the bag. The patient may then urinate orfurther defecate. In a preferred embodiment, the bag is retracted into aportion of the housing. An advantage of a device of the invention isthat the bag can be closed by the patient while the patient is stillseated on the device.

[0009] Also in a preferred embodiment, the housing is shaped to fit ontoa toilet seat. A preferred housing releasably attaches to the toiletseat or may comprise a non-slip surface for contacting the toilet. Thehousing may comprise padding to increase patient comfort. A preferredhousing is preferably constructed of cardboard or plastic but may beconstructed of any useful material. The housing may comprise supportsfor resting the apparatus on a toilet seat. The supports may be foldedover the housing for compact transportation of the apparatus.

[0010] A stool specimen collector of the invention comprises a bag forcollection, storage, and/or transport of the specimen. Preferably, a bagfor use in an apparatus of the invention is releasably attached to thehousing, preferably on the underside of the housing. In a preferredembodiment, the bag may be movably attached in a groove in the housingin order to facilitate closure of the bag. However, the bag may befixedly attached to the housing at the convenience of the manufactureror the technician. The bag is constructed of any suitable material suchas polyethylene or PVC, and is preferably opaque. In a preferredembodiment, the bag may contain a buffer, or other additives to retarddegradation of the specimen, and to optionally reduce odor.

[0011] A preferred apparatus comprises a slider attached to a drawstring for closing the bag. In a preferred embodiment, the bag comprisesa spring beam holding the bag in an open position. The spring beamdeforms to a closed position under the housing when the bag is closed.The slider is preferably engaged on the underside of the housing, suchthat when the draw string is pulled the slider sweeps the underside ofthe housing, thereby gathering the perimeter of the bag and causing thebag to close. In an alternative embodiment, the draw string itself isattached to the bag for closure and no separate slider is used. Thus,the draw string may be any material or configuration that is capable ofclosing the bag. It is not necessary for the draw string to remainattached to the bag after closure. Thus, the draw string may bedetachable. A preferred draw string is constructed of nylon, and may bea loop, straight chord, braided, or any other configuration capable ofclosing the bag. Preferred bag closure mechanisms include a flexibletongue and groove assembly, a zipper, a thermal seal, an adhesive, a“zip-lock” assembly and others known in the art to effect closure of theopen perimeter of a collection bag.

[0012] Also in a preferred embodiment, instructions for using theapparatus are attached to or printed on the housing.

[0013] Another embodiment of the invention provides methods forobtaining a stool specimen. In one embodiment, methods comprise placinga stool collector apparatus over a toilet, sitting over or on theapparatus, evacuating a stool into the collection bag, pulling the drawstring to close the collection bag, and retracting the collection bagunder the housing or bracket. A particular advantage of this embodimentis the collection bag is closed while the patient is still seated.

[0014] Additional aspects and advantages of the invention are apparentupon consideration of the following detailed description thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In the drawings, like reference characters generally refer to thesame part throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead being place upon illustrating theprinciples of the invention.

[0016]FIG. 1A is a bottom view of the stool specimen collectorapparatus.

[0017]FIG. 1B is a front view of the stool specimen collector apparatus.

[0018]FIG. 2A is a side view of the collection bag.

[0019]FIG. 2B is a side view of the integral assembly of the collectionbag, zipper and spring beam.

[0020]FIG. 3 is a schematic diagram illustrating the method of using thestool specimen collection apparatus.

[0021]FIG. 4A is a side view of the slider.

[0022]FIG. 4B is a front view of the slider.

[0023]FIG. 4C is a perspective view of the slider.

[0024]FIG. 4D is a perspective view of the slider showing the sliderclosure area.

[0025]FIG. 4E is a perspective view of the slider, zipper, collectionbag and draw string.

[0026]FIG. 5 is a perspective view of the slider, adhesive, collectionbag and draw string.

DETAILED DESCRIPTION OF THE INVENTION

[0027] Referring to FIGS. 1A and 1B, shown is a bottom view (1A) and aside view (1B) of a preferred stool specimen collector apparatus 10. Thestool specimen collector apparatus 10 comprises a housing 12 whichcomprises a center U-shaped support 14 which is connected to two sidesupports 16 and 18. The side supports 16 and 18 are hinged to centersupport 14 in such a way as to support the stool specimen collectorapparatus 10 when it is placed on a toilet (not shown), and to allow theside supports 16 and 18 to be folded under the center support 14 whenthe stool specimen collector apparatus 10 is not being used.

[0028] At least a portion of a collection bag 20 is attached to thecenter support 14. Preferably, the collection bag 20 is removablyattached to the center support 14. In FIG. 1A and FIG. 4E, the rearportion of the collection bag 20 is attached by rivets 22 through holes21 in a zipper flange 26C of a zipper 26 which is attached to thecollection bag 20. The rivets 22 then pass into holes 14C located in thecenter support 14. Alternatively, attachment of the collection bag 20 isaccomplished by other known methods, such as heat staking. FIG. 2A is aside view of the collection bag 20, and FIG. 2B is a side view of theintegral assembly of the collection bag, zipper 26 and spring beam 24.

[0029] As shown in FIGS. 1A and 1B, the front of the collection bag 20also includes a spring beam 24 which is preferably an integral part ofthe collection bag 20. The spring beam 24 is a narrow strip ofresiliently biased material but has sufficient vertical height toprevent vertical deflection of the collection bag 20 away from thecenter support 14. The spring beam 24 is initially flexed outward towardthe front of the toilet bowl when the apparatus is in use, and providessupport for the collection bag 20 in the open position.

[0030] A preferred collection bag 20 comprises a thin flexible plasticfilm or any other material known to those skilled in the art forcontaining a biological sample. The collection bag 20 may be opaque toprevent the individual from viewing the contents, or the collection bag20 may be clear to allow visual analysis by technicians.

[0031] As shown in FIG. 1A, FIG. 2A, FIG. 2B, and FIG. 4E, the top edgesof the collection bag 20 preferably have a zipper 26, in which the frontportion of the collection bag 20 contains a first portion of the zipper26A, and the back portion of the collection bag 20, which is attached tocenter support 14, contains a second portion of the zipper 26B. In oneembodiment of the first portion of the zipper 26A is the male portion ofthe zipper 26 and the second portion of the zipper 26B is the femaleportion of the zipper 26. In another embodiment the zipper 26 runs theentire length of the open perimeter of the collection bag 20. Apreferred zipper is an ITW Maxgrip UX202T. The collection bag 20 mayhave alternative closures, such as an adhesive closure, or others knownin the art.

[0032] Mounted to the underside of the center support 14 is a slider 28that runs along slider track 30. The slider 28 is attached to the zipper26 of collection bag 20. The slider 28 is attached to a draw string 32.The draw string 32 extends from the slider 28, around the center support14, under side support 16, and extends through an opening 34 in sidesupport 16. A handle 36 is attached to the end of the draw string 32 asshown in FIG. 1A.

[0033] In further detail, the slider 28 has two blocks 28A and 28B onits top edge as shown in FIG. 4A which also shows the draw string 32 isattached to block 28A. As shown in FIG. 4E, the draw string 32 is aheavy nylon monofilament which is molded by using heat into a high pitchhelix 32A, where the diameter of the helix 32A is equal to the width ofthe slider track 30, and is sufficiently large to prevent the drawstring 32 from falling out of the slider track 30 through the gapbetween the center support 14 and a slider track plate 14B. Blocks 28Aand 28B run in the slider track 30. A beginning portion of the zipper 26is zipped together while the collection bag 20 is open by sliding theslider 28 over the beginning portion of zipper 26. As a user pullshandle 36 and draw string 32, the slider 28 moves along the slider track30 which results in the female portion of the zipper 26B and the maleportion of the zipper 26A being brought together and engaged in theclosure area 28C of the slider 28.

[0034] The collection bag 20 is bonded together to both flanges of thezipper 26. The collection bag bond area 20B is above the holes 21 in thezipper flange 26C on the female portion 26B of the zipper 26, allowingrivets 22 to enter those holes 21 in the zipper flange 26C in the spacebetween the body of the collection bag 20 and the zipper flange 26C, andthen into the holes 14C in the center support 14. This arrangementpermits the bag assembly of the bag 20, the zipper 26 and the springbeam 24 to be removably affixed to the center support 14 withoutpenetrating the wall of the collection bag 20. FIG. 2B shows the springbeam 24 is creased near both ends of the beam at 24A to permit thespring beam 24 to assume either the open state shown in FIG. 1A, or theclosed U shape when the collection bag 20 is closed. A front edge of theslider 28D (FIG. 4D) deflects the spring beam 24, first into an S shapewhile the zipper 26 is being closed. Then when the slider 28 has reachedthe far end of the slider track 30, the spring beam 24 has become a Ushape in close proximity to the flange 14D of the center support 14. Thecollection bag 20 in the closed position is stored under the centersupport 14.

[0035]FIG. 5 illustrates an embodiment of the invention that uses anadhesive seal instead of a zipper to seal the collection bag 20 closed.FIG. 5 illustrates how a release paper strip 42 passes from the centersupport 14 (not shown), through a slider slot 28D, and onto an adhesivearea 27A on a top side of the collection bag 20. An end of the releasepaper strip is attached to the center support 14 above the startingposition of the slider 28 when the collection bag 20 is in the openposition. In one embodiment, the end of the release paper strip can beattached to the center support 14 by using a small clamp plate held downby a screw. In another embodiment, the end of the release paper stripcan be captured between the center support 14 and the slider track plate14B. The release paper strip 42 on the adhesive area 27A covers anadhesive 44. As the slider 28 moves along the slider track 30, therelease paper strip 42 is lifted off the adhesive 44. The slider closurearea 28C then pushes the adhesive area 27A, with the exposed adhesive44, together with an opposite top side of the collection bag 27B, toseal the collection bag 20 together forming an adhesive seal in a mannersimilar to the closure of zipper 26.

[0036] A method for using a stool specimen collector apparatus 10 isillustrated in FIG. 3. An individual places the stool specimen collectorapparatus 10 on a toilet 8. The user then sits on or over the stoolspecimen collector apparatus 10 and evacuates a stool sample 6 intocollection bag 20. The user then pulls draw string 32 via handle 36which closes the collection bag 20 by pulling the slider 28 which zipszipper 26 closed. As the collection bag 20 is being closed, the springbeam 24 at the front of collection bag 20 begins to deflect backwards inresponse to the zipper 26 closure which moves the closing collection bag20 under center support 14.

[0037] In addition, the stool specimen collector apparatus device 10 mayhave a drape 40 which covers the front of the collection bag 20. Thedrape 40 has an opening 38 in the top of the drape 40 to allow stool topass into collection bag 20. After a stool has been evacuated into thecollection bag 20, and as the collection bag 20 is being closed, thedrape 36 falls in to cover the collection bag 20 to protect thecollection bag 20 during the rest of the toileting process. Aftertoileting, the drape 40 can be detached and disposed.

[0038] A shipping container (not shown) may be used to ship the stoolspecimen collector apparatus, both prior to use, and after use toward alaboratory for analysis. The shipping container may contain one or moreover-bags (not shown) to contain the used stool specimen collectorapparatus 10 prior to placing the stool specimen collector apparatus 10into the shipping container. Alternatively, the side supports 16 and 18may fold over the housing 12 in order to form a shipping container.

[0039] It is envisioned that components of the stool specimen collectorapparatus are reusable. In one embodiment the support bracket 12, slider28 and draw string 32 are reusable.

[0040] Other aspects and advantages of the invention are apparent uponconsideration of the disclosure herein.

What is claimed is:
 1. An apparatus for collecting a stool specimen, theapparatus comprising: a housing; a collection bag attached to saidhousing; and, a draw string attached to said bag for use in closing saidbag
 2. An apparatus for collecting a stool specimen, the apparatuscomprising: a housing; a collection bag attached to said housing; aslider movably attached to said housing and capable of engagement withsaid collection bag; and, a draw string attached to said slider.
 3. Theapparatus of claim 1 , further comprising a center support.
 4. Theapparatus of claim 3 wherein said apparatus further comprises two sidesupports foldably attached to said center support, thereby to enablesaid side supports to fold under said housing when said apparatus is notin use.
 5. The apparatus of claim 4 wherein said housing is shaped toconform to a standard toilet seat.
 6. The apparatus of claim 1 whereinsaid housing has instruction printed thereon or enclosed therewith. 7.The apparatus of claim 1 wherein said collection bag is opaque.
 8. Theapparatus of claim 1 wherein said collection bag is closeable.
 9. Theapparatus of claim 1 wherein said collection bag further comprises aspring beam.
 10. The apparatus of claim 9 wherein said collection bag isretractable under said housing.
 11. The apparatus of claim 10 whereinsaid collection bag comprises a zipper.
 12. The apparatus of claim 10wherein said collection bag comprises an adhesive.
 13. The apparatus ofclaim 1 wherein said collection bag is removable from said housing. 14.The apparatus of claim 2 wherein said slider is slideable along anopening of said collection bag.
 15. The apparatus of claim 1 whereinsaid draw string comprises a handle.
 16. The apparatus of claim 1further comprising a drape, wherein said drape is attached to saidhousing.
 17. The apparatus of claim 16 wherein said drape is removable.18. The apparatus of claim 2 wherein said housing, said slider and saiddraw string are reusable.
 19. A method of obtaining a stool samplecomprising: evacuating a stool into said collection bag; and, pullingsaid draw string to close said collection bag and retracting saidcollection bag under said housing.